Regulatory Expert

Avan chemi


Posted 2 months ago

Job Description

● Collecting relevant documents and preparing documents to be presented in supervisory visits and inspections. ● Analyzing, and interpreting approvals, regulations, and guidelines of the regulatory organization. ● Communicating with regulatory agencies regarding potential regulatory inspections, regulatory requirements, or clarification and follow-up of submissions under review.


● Familiarity with GMP requirements. ● Familiarity with pharmacopeia standards. ● Proficient in regulatory matters and ability to write CTD. ● Sufficient familiarity with quality control laboratory processes. ● Proficient in following up on all technical, scientific, and pharmaceutical affairs of the company. ● Ability to communicate with the Food and Drug Administration. ● Proficient in English. ● Problem-solving skills. ● Attention to detail. ● Analytical thinking. ● Mastering the principles and techniques of negotiation. ● Ability to communicate effectively. ● At least three years of relevant work experience. ● Bachelor's or Master's degree in Chemistry.

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